CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report
Philips IntelliSpace Cardiovascular recalled by Philips Medical Systems
Philips Medical Systems Nederl is recalling Philips IntelliSpace Cardiovascular, distributed nationwide in the US. The recall was initiated on 4 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1252-2025
- FDA event ID
- 96129
- Recalling firm
- Philips Medical Systems Nederl, Eindhoven
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Apr 2024
- FDA classified
- 28 Feb 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 4 Apr 2024 | Recall initiated by company | |
| 28 Feb 2025 | Classified by FDA | +330 days |
| 12 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Philips IntelliSpace Cardiovascular software, Model 830089.
Where it was distributed
US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.
Nationwide AlaskaAlabamaArizonaCaliforniaConnecticutFloridaGeorgiaIowaIndianaKentuckyMassachusettsMichiganMinnesotaNorth CarolinaNebraskaNew YorkOhioOregonTennesseeTexas
Questions about this recall
Why was it recalled?
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Which lots are affected?
Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.
Where was it sold?
US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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